Testing the Safety and Efficacy of Commercial Drug Biktarvy in Subjects Known to Have the 184 Resistance Mutation to a Component in Biktarvy

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    22
  • sponsor
    Southampton Healthcare, Inc.
Updated on 25 January 2021

Summary

An Open-Label Study to Evaluate Switching from a Regimen of Elvitegravir/Tenofovir alafenamide/Emtricitabine/Cobicistat and Darunavir, to a Fixed-Dose Combination of Bictegravir/Tenofovir alafenamide/Emtricitabine in Virologically Suppressed HIV-1 Subjects who are known to have a I84 V/I Mutation

Details
Condition HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection
Treatment Biktarvy Tab
Clinical Study IdentifierNCT04040075
SponsorSouthampton Healthcare, Inc.
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have HIV-1-infection?
Do you have any of these conditions: Do you have HIV-1-infection??
The ability to understand and sign a written informed consent which must be obtained prior to initiation of study procedures
Age equal to or greater than 18 years
Currently receiving an ARV regimen of EVG/F/TAF +DRV greater than six month
Documented plasma HIV - 1 RNA less than 50 copies/ml during the treatment with Elvitegravir/F/TAF for a minimum of 12 months prior to screening, on two separate determinations, with one determination within 3 months prior to screening
Have a documented 184 V/I resistant mutation
HIV-1 RNA levels < 50 copies per ml at screening
Estimated GFR >than or equal to 30 mls/min
AST and ALT equal to or less than 5 times upper limit of normal
Total bilirubin less than or equal to 1.5 mg/dl or normal direct bilirubin
Adequate hematologic function (absolute neutrophil count equal to or greater than 750/mm to the third, platelets equal to or greater than 50,000/mm to the third, Hemoglobin equal to or greater than 8.5 g/dl)
Persons of child bearing potential must have negative serum pregnancy test at screening
Male participants and persons of child bearing potential who engage in heterosexual intercourse must agree to use our protocol specified methods of contraception
Female participants must agree to refrain from egg donation from first dose of FDC of B/F/TAF and throughout the study
Male participants must agree to refrain from sperm donation from first dose until at least 30 days after last dose of drug
Life expectancy equal to or greater than one year

Exclusion Criteria

No desire to switch from current antiretroviral treatment
Any previous use of B/F/TAF
Any opportunistic illness indicative of stage 3 HIV diagnosed within 30 days prior to screening
Malignancy within 5 years of screening other than cutaneous Kaposi's sarcoma, completed resected non melanoma skin cancer, basal cell carcinoma, or noninvasive cutaneous squamous carcinoma, or completed resected carcinoma in situ of the cervix or anus. A prior malignancy treated with curative therapy and for which there has been no evidence of disease for at least 5 years prior to screening
Known hypersensitivity to FDC of B/F/TAF tablets their metabolites or formulation
No active treatment of Hepatitis C during the 48 weeks of the study
Females who are pregnant confirmed by serum pregnancy test
Females who are breast feeding
Suspected Biktarvy resistance mutations, except 184 V/I
Patients who need to take Dofetilide, Rifampin, Rifapentine, Rifabutin, phenobarbital, phenytoin, carbamazepine, oxcarbazepine, and antiretrovirals not part of the study and St. John's Wart during
Acute Hepatitis in the 30 days prior to screening
Active tuberculosis infection
Current alcohol or substance use judged by the investigator to potentially interfere with subject study compliance
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